510(k) K910875
K910875 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLE". The FDA issued a decision of Substantially Equivalent on March 19, 1991. The device falls under product code FDP (Apparatus, Pneumoperitoneum, Automatic), a Class II device regulated under 21 CFR 876.1500. ETHICON, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 1991
- Date Received
- March 1, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Pneumoperitoneum, Automatic
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- SU
- Submission Type